Moderna Therapeutics has become the latest company to announce delays to its clinical trial program caused by the COVID-19 pandemic, halting enrolment in a number of its mRNA-based candidates.
The Cambridge, MA-based firm has shot to prominence since January when it became one of the first companies to declare its goal to develop a vaccine against COVID-19.
The company’s share price has soared 30% since the start of the year, thanks to its lead in the field, with this NIH-partnered vaccine called mRNA-1273 entering Phase I trials in record time on 16 March.
The hope is that it could receive accelerated approval within 12 months to help repel the pandemic – but meanwhile the outbreak is disrupting other applications of its mRNA platform.
The company says that the ‘lockdown’ now in place across the US and much of Europe aimed at halting the spread of the coronavirus had made it difficult for patients, including children and adolescents with rare diseases and their caregivers, to take part safely in trials.
It has therefore decided to pause new enrolment of several trials in some infectious and rare diseases, while maintaining activity in cancer trials.
It is suspending sign-ups for two Phase I rare disease clinical trials - methylmalonic acidemia (MMA; mRNA-3704) and propionic acidemia (PA; mRNA-3927) for patient safety reasons, and no patients have been dosed to date.
Moderna has also been notified that enrolment of further subjects in its chikungunya virus antibody trial (mRNA-1944) has been paused by the site in Austin, Texas, due to the impact of COVID-19.
In oncology, the company says it is continuing to treat current patients and enrol new patients in studies, including its personalized cancer vaccine (mRNA-4157), triplet (mRNA-2752) and OX40L (mRNA-2416) programs.
However it has warned that challenges created by the pandemic are leading to delays in enrolment, and says it is evaluating the initiation of new cancer trial sites using a risk-based framework.
Ahead of its coronavirus vaccine, mRNA-4157 (partnered with Merck & Co. Inc..) is one of the firm’s two most advanced candidates, along with mRNA-1647, a cytomegalovirus (CMV) vaccine, both in Phase II studies.
Like other biopharma companies, Moderna has also seen its operations directly hit by the lockdown in the US. Since 12 March, many of its employees have been working remotely, though essential in-person laboratory, manufacturing and related functions continue on site in Boston.
The announcement of the trial delays has hit the company’s share price, which fell 3% on the news. However market sentiment remains that Moderna’s COVID-19 vaccine candidate could be transformative against the pandemic and for the company, if it can demonstrate good safety and efficacy, with early results expected within two months.